Combination Chemotherapy in Treating Patients With Advanced or Metastatic Colorectal Cancer

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced or metastatic colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swiss Group for Clinical Cancer Research
• Treatments: Camptothecin; Capecitabine; Irinotecan

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed advanced or metastatic colorectal cancer

• Unresectable disease

• At least 1 bidimensionally measurable lesion

• At least 2 cm in perpendicular diameters

• No evidence of CNS metastases

PATIENT CHARACTERISTICS:

Age:

• 18 to 75

Performance status:

• 0-1

Life expectancy:

• At least 3 months

Hematopoietic:

• WBC at least 3,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin normal

• SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN)

• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.25 times ULN

Cardiovascular:

• No clinically significant cardiac disease

• No congestive heart failure

• No New York Heart Association class III or IV heart disease

• No symptomatic coronary artery disease

• No uncontrolled cardiac arrhythmia

• No myocardial infarction within the past year

Gastrointestinal:

• No evidence of dysphagia

• No malabsorption or intestinal obstruction that would affect absorption or excretion of study drugs

• No chronic diarrhea

Other:

• No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or localized nonmelanoma skin cancer

• No psychiatric disability that would preclude study compliance

• No other significant medical condition

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for advanced or metastatic disease

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• At least 4 weeks since prior major surgery to the gastrointestinal tract

Other:

• No concurrent therapy for history of seizures or CNS disorder